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Comparison of Outcomes for Single vs Double Pyloromyotomy for Gastroparesis Randomized Controlled Trial

NCT06173336 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-06-25

No results posted yet for this study

Summary

Gastroparesis is a chronic disease of the stomach that causes delayed gastric emptying without stenosis. The clinical symptoms of gastroparesis include nausea, vomiting, early satiety, post-prandial fullness, bloating, belching, and upper abdominal discomfort Gastroparesis cardinal symptoms index (GCSI) is a reliable, reproducible, and valid instrument for measuring symptom severity in patients with gastroparesis.

This will be a randomized controlled trial of all the patients who are referred to the University of Arkansas Medical Sciences (UAMS) for gastric peroral endoscopic pyloromyotomy (G-POEM) for treatment of refractory and severe gastroparesis. During G-POEM procedure, either single or double pyloromyotomy will be performed with randomization. The aim is to compare clinical outcomes and the efficacy of single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis.

Conditions

Interventions

PROCEDURE

gastric per-oral endoscopic myotomy (G-POEM)

Comparing single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Sumant Inamdar, MD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2025-06-17
Completion
2025-06-17

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173336 on ClinicalTrials.gov